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Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI)Versus a CNI-free Treatment in Renal Transplantation (CIME) (CIME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01595984
Recruitment Status : Unknown
Verified August 2018 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was:  Active, not recruiting
First Posted : May 10, 2012
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

The main objective of this protocol is to compare the impact on renal function of two different immunosuppressive regimens in patients with de novo renal transplant.

Renal function will be accurately evaluated by measuring the clearance of iohexol.

The protocol will also evaluate the efficacy and safety in a short term of these two different immunosuppressive regimens.


Condition or disease Intervention/treatment Phase
Kidney Failure Drug: cyclosporin + mycophenolate mofetil Drug: everolimus + mycophenolate mofetil Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Multicenter, Open-label, Comparative Study of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI), Associating Myfortic ® and Neoral ® Compared to a CNI-free Treatment, Combining Myfortic ® and Certican ® , in Adult Patients With de Novo Renal Transplant
Actual Study Start Date : May 3, 2012
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018


Arm Intervention/treatment
Active Comparator: Cyclosporin + Mycophenolate mofetil Drug: cyclosporin + mycophenolate mofetil
antirejection drug, renal transplantation

Experimental: Everolimus + mycophenolate mofetil Drug: everolimus + mycophenolate mofetil
antirejection drug, renal transplantation




Primary Outcome Measures :
  1. Evolution of glomerular filtration rate measured by clearance of iohexol [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and Females aged between 18 and 70.
  • Patient receiving a first or second kidney transplant from a deceased donor, living related or unrelated.
  • Patient with a maximum PRA <20%.
  • Patient wishing and being able to participate fully to the study, and having given a written consent.
  • Patient covered by a social insurance or beneficiary of such a regime.
  • Women of childbearing age must use a recognized method of contraception throughout the study period and continue for 8 weeks after discontinuation of study treatment.

Exclusion Criteria:

  • Patient receiving a kidney from a heart attack donor , or an ABO incompatible donor or a donor with a positive T-cross match.
  • Patient with a maximum PRA> 20% twice.
  • Cold ischemic time > 36 hours.
  • Patients with thrombocytopenia (<75000/mm3), neutropenia (<1 500 / mm3), leukopenia (<2 500 / mm3) or a hemoglobin concentration <8 g / dl, at inclusion visit.
  • Patient with severe hyperlipidemia: total cholesterol ≥ 9 mmol / l (≥ 3.50 g / l) and / or triglycerides ≥ 8.5 mmol/l (≥ 7.5 g / l) despite appropriate lipid-lowering therapy.
  • Patient with known HIV positive status, know active hepatitis B or C. Recipients of an organ from a donor with positive HIV status, hepatitis B or hepatitis C are excluded.
  • Patient with severe systemic infections requiring continued therapy.
  • Treatment with an experimental drug within 4 weeks before the first dose of study treatment.
  • Patient for whom the initial disease or other pathology requires a long-term corticosteroid treatment.
  • Patient with a history of hypersensitivity or known contra-indications for macrolide or inhibitors of mTORs drugs; drugs similar to Myfortic ® (ERL080) or other components of the formulation such as lactose, or cyclosporine, or prednisone (Cortancyl ®), or Thymoglobuline ® or Iohexol.
  • Patient with a malignant disease or a history of malignancy over the past 5 years except squamous-cell or basal cell carcinoma wich was excised.
  • Medical condition or surgical procedure, except transplantation, which could exclude the patient in the opinion of the investigator.
  • Patient with symptoms of mental or significant somatic illness. Disability to cooperate or communicate with the investigator.
  • Pregnant, sucking or of childbearing age and refusing or being unable to use a recognized contraceptive method.
  • Patient under guardianship, or any patient protected by law.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595984


Locations
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France
Nephrology department, Hospital University of Amiens
Amiens, France, 80000
Nephrology Department, University Hospital of Montpellier
Montpellier, France, 34285
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Novartis
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01595984    
Other Study ID Numbers: PI10-PR-CHOUKROUN
2011-001385-18 ( EudraCT Number )
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Keywords provided by Centre Hospitalier Universitaire, Amiens:
kidney
transplantation
graft
creatinin
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cyclosporine
Mycophenolic Acid
Everolimus
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antineoplastic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents